Brain Indices of Risk for Posttraumatic Stress Disorder (PTSD) After Mild Traumatic Brain Injury (mTBI)

PTSD Clinical Trial

Official title:

Brain Indices of Risk for Posttraumatic Stress Disorder After Mild Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625962
• Other study ID #: INTRuST-BRI
• Status: Completed
• Phase: N/A
• First received: June 20, 2012
• Last updated: February 27, 2018
• Start date: October 2011
• Est. completion date: March 2016

Study information

• Verified date: August 2015
• Source: INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, longitudinal cohort study to evaluate the associations between indices of brain structure and function (measured at baseline, as soon as possible after injury) and course of post-traumatic stress disorder (PTSD) symptoms. Subjects will be service members who have sustained mild traumatic brain injury (classified as either "impact-induced mTBI" or "blast-induced mTBI"; n = 100 completers) or an extracranial injury (ECI) with no evidence of traumatic brain injury (TBI) (n = 100 completers). Subjects will complete an assessment battery at baseline and 6 months later that includes (1) structural magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI) derived from a 3-Tesla magnet; (2) event-related brain potentials (ERPs) derived from brain electrical activity; (3) neurocognitive tests; and (4) neurological soft signs (NSS). Specific indices of brain structure and function derived from these assessments are hypothesized to demonstrate a significant relationship with course of PTSD symptoms, which will be measured at baseline, 3 months, and 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: March 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Injured while deployed or stateside

2. Must be diagnosed TBI positive or certified as TBI negative by a licensed medical practitioner using Department of Defense (DoD) criteria

3. For mTBI subjects, an initial score of 13-15 on the Glasgow Coma Scale

4. Aged 18-50

5. Defense Enrollment Eligibility Reporting System (DEERS) eligible

Exclusion Criteria:

1. Unable or unwilling to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization ("unable" includes cases in which the potential subject cannot read and understand English well enough to provide informed consent)

2. Penetrating head injury

3. Medical chart reveals a history of significant neurological condition(s) (reviewed on a case by case basis)

4. Diagnosis with or undergoing treatment for an illness that could affect brain function (reviewed on a case-by-case basis)

5. History of major psychiatric condition(s) that interfere with daily functioning as revealed in the medical chart or by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID)

6. Record of drug or alcohol abuse or dependence in the past six months as documented in medical history review

7. Medical chart or SCID reveals current or lifetime PTSD diagnosis related to non-combat life events that occurred prior to most recent deployment

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Fort Belvoir Community Hospital	Fort Belvoir	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between brain structure and function and PTSD symptoms, as measured by the Clinician-Administered PTSD Scale (CAPS)	To evaluate the associations between (1) baseline indices of brain structure and function and (2) course of PTSD symptoms in service members with TBI and ECI over the 6-month follow-up period.	Change between Baseline and 3-months and 6-months
Secondary	Correlation between brain structure and function and cognitive, functional, headache, behavioral and quality of life measures	To evaluate the associations between (1) the selected baseline indices of brain structure and function, and (2) course of post-concussive symptoms, self-reported health status, including headache, overall emotional distress, and quality of life over the 6-month follow-up period.	Change between Baseline and 3-months and 6-months
Secondary	Evaluate effect of injury type and brain structure and function	To evaluate the effect of type of injury (impact TBI vs. blast TBI vs. ECI) on selected indices of brain structure and function at baseline and at the 6-month follow-up period.	Change between Baseline and 3-months and 6-months